Regulation Enters Into Effect for Clinical Research and Studies Into Cosmetic Products and Raw Materials

The Regulation on Effectiveness and Reliability Studies and Clinical Research of Cosmetic Products or Raw Materials (“Regulation”) has entered into effect. The Regulation was prepared by the Turkish Pharmaceuticals and Medical Devices Agency (“Agency”) and published in Official Gazette number 29481 on 20 September 2015. It outlines procedures and principles for conducting effectiveness studies regarding cosmetic products or their raw materials, as well as reliability studies and clinical research on volunteers. It also addresses protection of volunteer rights and working principles for the Cosmetic Clinical Research Ethical Board.

Significant provisions in the Regulation include:

– General principles for studies or research conducted on volunteers (Article 5). In particular, the Regulation states:

– If the study or research involves cosmetic products or raw materials, research must first be conducted in a non-human test environment.

– Reliability assessments must be conducted before studies and research into cosmetic products or raw materials can occur (Article 5(a)-(b)).

– Clinical research regarding cosmetic products or raw materials can only be conducted in places which (Article 9):

– Ensure the safety of research subjects and are suitable for conducting research in a healthy manner, as well as conduct follow-ups and emergency interventions, if necessary.

– Are one of the following:

– University health practice and research center.

– Authorized research-development center, affiliated to a university.

– Ministry of Health training and research hospital.

– Laboratory with personnel, equipment and laboratory facilities consistent with the quality of the research.

– Applications for studies and research can be made to the Agency by a supporter, contracted research institution assigned by the supporter or principal investigator. Certain applications require permission from the Ethical board and in these cases, studies and research can only begin after receiving Agency permission.

If the Agency declines a research or clinical study application, it will provide a justified decision to the applicant. The applicant receives a single opportunity to re-apply with the necessary application amendments, or object to the Agency’s decision (stating justifications). The Agency can reject the second research application if the amendments are not satisfactory, or the applicant’s objection is not admissible (Article 10).

– After producing and importing cosmetic products or their raw materials, the supporter, contracted research institution assigned by the supporter or the principal investigator are responsible for storage of cosmetic products or their raw materials (depending on which party made the application). This party is also responsible for distribution and delivery to the research center, as well as disposal (if required). Records must be kept regarding all these processes (Article 14).

– The Agency will conduct or commission an audit of the following places and entities regarding compliance with the Regulation and other relevant legislation, without being required to provide notice (Article 25):

– Centers where clinical research into cosmetic products or raw materials is occurring on volunteers.

– The supporter and contracted research institution.

– Manufacturing sites for the cosmetic products or raw materials which are being researched.

– Laboratories where research analysis occurs.

– Ethical boards.

– Where situations arise which are not specifically addressed by the Regulation, provisions of other relevant legislation will apply, along with the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine Convention for the Protection of Human Rights Dignity with Regarding The Application Of Biology and Medicine, Medical Deontology, Ordinance (Article 29).

Please see this link for full text of the Regulation (only available in Turkish).

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Constitutional Court Rules on Property Rights and Public Interests Within the Context of Land Use Plans

In a recently published decision, an applicant to the Constitutional Court claimed that its property rights were violated by an administrative action. The legal entity applicant’s gas station had been classified partially as a “transportation and transfer area” and partially as “parks and rest areas” under the Land Use Plan Aiming at Protection of Beyoğlu Urban Protected Area of Istanbul Metropolitan Municipality (“Administration”) dated 21 May 2008 (“Land Use Plan”). The Constitutional Court evaluated the material facts and ruled that the applicant’s property rights had not been violated on the basis no imbalance existed between public interest requirements and the applicant’s property rights.

The applicant claimed to the Constitutional Court that its property right had been violated in the following ways:

– The Land Use Plan has not been regularly and duly prepared.

– The Administration has used indefinite and ambiguous phrases about public interest in the decision regarding public interests, meaning the Administration’s action is not based on public interests.

– The gas station will decreased in value due to the Land Use Plan and the Administration did not take the applicant’s legitimate expectations into account under the Land Use Plan.

The Constitutional Court held the Administration’s property classification considerably limited the applicant’s use of the property. Accordingly, the court held there was a clear interference with the applicant’s property rights. The Constitutional Court assessed the interferences against Articles 13 and 35 of the Constitution, regarding restriction of fundamental rights and freedoms, as well as property right.

The Constitutional Court discussed the concept of public interest, emphasizing that property rights can only be restricted by legislation and for the public interest. The court noted that public interest must be evaluated on a case-by-case basis and cannot be objectively defined. It went on to state that the burden of proof rests with the party who claims an interference is against public interests.

The Constitutional Court notes that although the expert report criticizes the Land Use Plan in general terms, the report does not clearly say that the Administration’s action was counter to public interests in the applicant’s specific circumstances. The Constitutional Court states that the applicant’s claim regarding the absence of public interest was rejected by the Administrative Court and the applicant failed to prove the absence of general interest before the Administrative Court. As a result, the Constitutional Court concluded that the Administration’s decision about public interest has legal basis.

The Constitutional Court emphasized the necessity of a reasonable balance between public interests which the Land Use Plan is intended to support, compared to restrictions on the applicant’s property rights, pursuant to the principle of proportionality. Within this framework, the Constitutional Court applied the principle of proportionality to the case at hand. It concluded that the situation caused by the Administration’s restrictions did not create an imbalance between public interest requirements and the applicant’s property rights. Therefore, the Constitutional Court ruled that the applicant’s property rights had not been violated.

The full text of the Constitutional Court’s reasoned decision was published in Official Gazette number 29479 on 18 September 2015 and can be found at this link (only available in Turkish).

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Constitutional Court Rules That Property Expropriation Without Due Process or Payment Constitutes Violation of Property Rights

The Constitutional Court recently considered a claim that the Istanbul Water and Sewerage Administration (“IWSA”) violated an applicant’s property rights under Article 35 of the Constitution by confiscating property without completing expropriation procedures, or paying the expropriation price. In its decision, the Constitutional Court held that the applicant’s property rights have been violated and the case should be re-examined to eliminate the consequences of the violation.

In the case at hand, the IWSA held an expropriation decision regarding the property, issued against a previous owner of the property. The previous owner had disputed the expropriation decision and the expropriation price was blocked in the previous owner’s bank account. However, the property was later sold to the applicants, without any expropriation annotation existing in the land registry records. The administration later entered an expropriation annotation on the land registry records, without notifying the new owners (the applicant) nor paying the expropriation price to the new owner. Accordingly, the administration confiscated the applicants’ property based on an expropriation decision made against the previous owner.

The Constitutional Court considered whether:

– An intervention to the property rights occurred.

– Legitimate grounds exist for an intervention.

– The essence of property rights are infringed.

– Restriction of the property right is necessary.

– The instruments used for the purposes of the restriction are proportionate.

The Constitutional Court held the applicants’ property rights were violated by the administration confiscating the property, without completing expropriation processes or paying the expropriation price. The court ruled in this way, even though an expropriation annotation had been entered in the land registry records.

According to court decisions, if an expropriation process has not been completed, a lawful expropriation does not exist pursuant to Article 46 of the Constitution. Therefore, IWSA’s confiscation in these circumstances is considered a tortious act and the applicants retain property rights despite the confiscation. Lawsuits in these circumstances are not subject to the statute of limitations which generally requires actions to be initiated within 30 days of the expropriation.

The full text of the Constitutional Court’s reasoned decision (2013/3667, dated 10 June 2015) was published in Official Gazette number 29479 on 18 September 2015 and can be found at this link (only available in Turkish).

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Constitutional Court Rules on Violation of Property Rights for Evacuation Order Without Compensation

The Constitutional Court recently considered a claim that an applicant’s property rights had been violated regarding real estate for which it held a “title allocation deed”, first obtained in 1985. The real estate was classified as a natural protected area by Istanbul 3rd Cultural and Natural Heritage Preservation Board. The court noted that generally, such a deed is not considered to be a property right. However, the court held that in these circumstances, the applicant had established a property right due to the administration’s failure to object to long-term use of the real estate. Therefore, the Constitutional Court held that an evacuation order, given without compensation, violated the applicant’s property rights (2013/6670; 6 October 2015).

The applicant originally initiated a lawsuit before the Administration Court against an evacuation order made by the General Directorate of National Real Estate. The Administrative Court rejected the case and the rejection was later approved by the Council of State. The case was then brought before the Constitutional Court.

Cancellation of the Title Allocation Deed:

The Constitutional Court clarified that a title allocation deed simply certifies the subject real estate is held by such individual; it does not impose any obligation on the administration to grant a title deed. The court referred to a European Court of Human Rights’ (“ECHR”) opinion which states that where a title allocation deed is granted for real estate, the real estate is deemed to be public property. The court notes that it is established that a title deed represents a property right and can be asserted against anyone. However, the court held that the expectation of the title allocation deed owner with respect to a property right is not subject to Constitutional protection. Therefore, the court rejected the title applicant’s claims due to lack of jurisdiction over the subject matter.

Evacuation without Compensation:

The applicant had used the real estate since 1972 and paid taxes since 1981, without any objections from the Department of Treasury. Accordingly, in line with the ECHR precedents, the Constitutional Court accepted that the applicant had established a property right. The court held that demolishing the real estate and evacuating the applicant without compensation violated the applicant’s property rights.

The Constitutional Court held that failing to pay the real estate’s value or offer any compensation violated the principle of proportionality. The court emphasized that for an interference with property rights to be deemed proportional, the payable amount must be adjusted for inflation.

The Constitutional Court rejected the applicant’s compensation claims. The court reasoned that the applicant is entitled to initiate a lawsuit to obtain the real estate’s value and determining the compensation amount requires a trial.

The full text of the Constitutional Court’s reasoned decision (2013/6670, dated 10 June 2015) was published in Official Gazette number 29479 on 18 September 2015 and can be found at this link (only available in Turkish).

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Constitutional Court Rules on Right to Receive a Justified Decision

In a recently published decision, the Constitutional Court held that an applicant’s right to a fair trial was breached when the court of first instance failed to consider some of the applicant’s arguments on a particular topic. Accordingly, the Constitutional Court held that the applicant’s right to receive a justified decision had been violated and the court of first instance should re-examine the lawsuit. The higher court also awarded non-pecuniary damages as compensation for a violation of the applicant’s right to receive trial within a reasonable time.

The applicant sought re-examination of the initial lawsuit and compensation for damages on the basis that her right to a fair trial was breached because she claimed:

– The statute of limitations provisions were misapplied.

– The court did not respond to the applicant’s objections about the statute of limitations.

– The trial was not conducted within a reasonable time period.

The Constitutional Court noted that it is not bound to strictly consider the specific violations alleged by parties. In line with this discretion, the court considered the applicant’s right to a fair trial, particularly focusing on her right to receive a justified decision and have a trial within a reasonable time.

The Constitutional Court commented that the requirement to present justified decisions must be considered taking into account the characteristics of each decision. Accordingly, the court emphasized that, the court of first instance’s failure to consider the applicant’s complaints in relation to their appeal of substantial issues which have not been discussed by the court of first instance would be considered to be a breach of an applicant’s right to receive a justified decision. Accordingly, the Constitutional Court held that the Supreme Court decision had not discussed the essential terms of the applicant’s complaint, raised before the court of first instance. Therefore, the Constitutional Court found a violation of the applicant’s right to receive a justified decision.

Although the Constitutional Court acknowledged the trial process was complicated, it held that an unreasonable delay occurred. Accordingly, it held the applicant’s right to trial within a reasonable time had also been violated.

Overall, the Constitutional Court ruled that the applicant’s right to a fair trial has been breached and the court of first instance should re-examine the lawsuit.

Since the lawsuit would be re-examined, the Constitutional Court rejected the applicant’s claim for monetary damages. However, it awarded compensation for non-pecuniary damages arising from violation of the applicant’s right to receive trial within a reasonable time.

The full text of a Constitutional Court decision (2014/4106, dated 10 June 2015) was published in Official Gazette number 29479 on 18 September 2015 and can be found at this link (only available in Turkish).

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Constitutional Court Rules That a Verdict Based on Irrelevant legislation Violates the Right to Fair Trial

The Constitutional Court recently considered the right to a fair trial. It held that the applicant’s right to a fair trial had been violated because the first instance court had based its verdict on irrelevant legislation. Accordingly, the Constitutional Court sent the case back to the first instance court to be re-examined.

The applicant argued that her right to a fair trial and the legality of crime and punishment principle had been violated on the basis the first instance court had rejected her earlier cancellation action regarding an administrative traffic fine, where the court’s reasoning was not relevant to the material facts.

The Constitutional Court upheld the applicant’s claim, emphasizing that all persons are constitutionally entitled to seek legal remedies and all court verdicts must indicate the justification for their decision. The court noted these rights arise from the Turkish Constitution (Article 36, right to fair trial; Article 141, publicity of hearings and the necessity of justified verdicts) and the European Convention on Human Rights (Article 6, right to fair trial).

The Constitutional Court noted that the court of first instance’s decision discussed driving without a license and issuing an administrative fine to the plate owner, rather than whether the driver complied with the law in these specific circumstances. According to the Constitutional Court, the verdict by the court of first instance is based on irrelevant legislation because the administrative fine is given for exceeding the speed limit and such fine should also be served to the plate owner. As a result, the Constitutional Court returned the matter to the court of first instance to be re-examined.

Dissenting judges in the Constitutional Court’s decision commented that serving the administrative fine to the plate owner does not violate the right to a fair trial. These dissenting judges noted:

– Previous Constitutional Court decisions show that where a legal or physical assumption exists, the burden of proof may shift to the accused party. However, the shifting burden does not violate the presumption of innocence, nor the right to fair a trial. Therefore, the dissenting judges commented that in the case at hand, the administrative fine can be served to the plate owner as well as the driver, since the identity of the driver cannot be easily determined.

– The relevant traffic rule’s purpose is to protect public order, as well as society’s health and security. Therefore, legislators can restrict several rights without exceeding citizen’s constitutional rights.

– Where there is no serious damage to the applicant, the Constitutional Court can rule applications as inadmissible, provided the application does not raise significant issues about applying and interpreting the Constitution, or determining the scope and limitations to fundamental rights.

The full text of the Constitutional Court’s reasoned decision (2014/1292, dated 10 June 2015) can be found at this link (only available in Turkish).

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Constitutional Court Rules on Unreasonable Delays Within the Right to Fair Trial

The Constitutional Court recently considered a claim that a land expropriation violated the applicant’s right to a fair trial due to the judgment processes lasting five years and ten months during administrative procedures. The Constitutional Court held that the applicant’s rights have been violated by the judgement process not being completed within a reasonable period of time.

The applicant sought to annul a decision regarding expropriation of his land which was made for the purposes of investing in housing, industry, education, health and tourism and establishing public facilities. Before the Constitutional Court, the applicant claimed his rights to a fair trial and property rights have been violated on the basis that:

– The expropriation’s purpose was not clearly stated and accordingly there were no public interests involved.

– Decisions by the court of first instance and Council of Ministers do not contain any concrete reasoning.

– Disagreements about the expropriation price mean that an expropriation performed below the property’s real value would contradict the expropriation’s purpose.

– A judgement on the dispute was not issued within a reasonable period of time.

Under Article 80 of the Constitution, the state and other public legal entities can expropriate private property, provided the property’s real value is paid and the expropriation is made pursuant to laws and in the public interests. The Law on Land Development and Utilization empowers the Land Office General Directorate (and Housing Development Administration of Turkey (“TOKI”) to expropriate land for the purposes of investing in housing, industry, education, health and tourism and establishing public facilities.

In the case at hand, the Constitutional Court held despite TOKI failing to clearly state the expropriation purpose (referring to all legislative purposes as a whole), this does not necessarily mean there are no public interests involved, nor render the expropriation illegal.

Expropriations made below the real property value will constitute an excessive interference with property rights under the proportionality principle (Article 13 of the Constitution), exceeding any intended public interests associated with the expropriation. In this case, the Constitutional Court held that no violation of property rights occurred in this respect because TOKI paid the applicant the court-determined expropriation price.

The Constitutional Court adopted a similar stance to previous decisions regarding the right to fair trial, where a judgment is not issued within a reasonable time. The Constitutional Court referred to its past decisions on the issue, as well as decisions by the European Court of Human Rights. The court held that a judgement process lasting five years and ten months constituted a violation of the applicant’s right to a fair trial.

The full text of the Constitutional Court’s reasoned decision (2013/395, dated 10 June 2015) was published in Official Gazette number 29479 on 18 September 2015 and can be found at this link (only available in Turkish).